Morning Versus Evening Dosing of Antihypertensive Medications: A Pilot Study to Assess Feasibility and Efficacy

Completed · Not applicable

Conditions studied: Hypertension

In brief

Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Ambulatory blood pressure (BP) monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Importantly, elevated nighttime BP is a modifiable risk factor; evening dosing of antihypertensive medications lower nighttime BP and reduces proteinuria. In a large, randomized controlled trial, evening dosing of antihypertensive medications reduced the hazard rate for major cardiovascular events by 67%. Findings were similar in the subgroup of participants with chronic kidney disease (CKD). However, this single-center study was designed to evaluate cardiovascular outcomes, not progression of CKD. The long-term effect of nighttime dosing of antihypertensive medications on progression of CKD is unknown. To address this important gap in knowledge, the investigators plan to conduct a pragmatic, randomized controlled trial. 3600 participants at risk for progression of CKD who are taking ≥1 antihypertensive medication once daily will be randomized to morning versus evening dosing of at least one antihypertensive medication. The purpose of the current study is to obtain pilot data demonstrating the feasibility of the trial and the efficacy of the intervention.

Key facts

Study ID

NCT01965847

Run by

University of Minnesota

People needed

79

Starts

2013-11-01

Expected to finish

2015-04-17

Last updated by the study team

2017-12-29

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with moderate to severe kidney disease, defined as:
• Estimated glomerular filtration rate 20-45 mls/min/1.73m2; or
• Estimated glomerular filtration rate: 45-60 mls/min/1.73m2 with proteinuria defined by either a urine albumin to creatinine ratio >300mg/g or a urine protein to creatinine ratio >500mg/g.
• Age 19-80 years
• Taking one or more non-diuretic antihypertensive medication once daily
• Appointment at the University of Minnesota Medical Center Renal Clinic.

You may not qualify if…

• Pregnant women
• Patients that are difficult to follow-up with: prisoners, non-English speakers
• Patients with adherence difficulty: Mentally disabled, emotionally disabled, developmentally disabled, impaired decision making capacity.

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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